Device product
Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and turns to protect patients throughout the hospital journey. Through immersion and envelopment, the WAFFLE Overlay is designed to offload the patient and relieve pressure at bony prominences while the unique venting holes allow for air circulation to keep patients cool, dry and comfortable.
Z-2640-2020
Product summary
- Firm
- EHOB, Inc.
- Event
- Event 85870
- Status
- Terminated
- Classification
- Class II
- Quantity
- 173
- Official record key
device-enforcement:Z-2640-2020
Official wording
Reason: QC inspection observed that a portion of the lot may have been contaminated with blood.
Code information: Lot 93649FA
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
QC inspection observed that a portion of the lot may have been contaminated with blood.